FDA 510K DATABASE SKIN
FDA 510K DATABASE ISO

In Vitro Diagnostics Master Handbook - Over 500 Pages including EU Directive 2017/746ĭon't see what you are looking for? Contact John Cuspilich, QA/RA, at Inventory: Handbooks are up-to-date as of date purchased! 21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product MasterĢ1 CFR 11 - Electronic Records with Scope & ApplicationĢ1 CFR 11 - Electronic Records with Scope & Application and Part 11 ChecklistĢ1 CFR 11 - Electronic Records with Scope & Application and PreamblesĢ1 CFR 11 - with Scope & Appl.

GMP Medical Device Master Reference Guide - Over 900 pages including EU Directive 2017/745ĭietary Supplement Master Handbook - Includes Guides and Regulations for SupplementsĢ1 CFR Part 117 - GMPs Hazard Analysis, and Risk-Based Preventive Controls for Food Master Reference Guide - 900+ pages of Guidance and Regulations

FDA 510K DATABASE ISO

Get the Regulations and Guidance Handbooks:Ģ1 CFR 210/211 - Drug GMPs - Add Parts 11 Electronic Systems and 820 QSR for DeviceĢ1 CFR 820 - Quality System Regulations - Include Audit Checklist with ISO 13485 ReferencesĢ1 CFR 112 Produce for Human Consumption also in a combination English / SpanishĢ1 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice HandbookĢ1 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device CombinationĢ1 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - Good Clinical Practice Handbook

FDA 510K DATABASE SKIN

Handbooks Drug/Device MedWatch CBER (Biologics) CDERĪcne ADD and ADHD AIDS/HIV Allergies Alzheimer's Arthritis Asthma Autism Back Pain Birth Control Cancer - Breast Cancer - Prostate Cholesterol Common Cold | Flu Crohn's & Colitis Dental Health Diabetes Diet & Nutrition Ear Disorders Epilepsy Erectile Dysfunction Glaucoma Hair Loss Headache | Migraine Heartburn HeartĪttacks Hepatitis Hemorrhoids Kidney Lyme Disease Men's Health MRSA Multiple Sclerosis Osteoporosis Parkinson's SARS SIDS Skin Care Sleep Disorders Smoking Snoring Stress | Depression Stroke Vitamins Taught by John Cuspilich, CEO, The Auditing Group - Sign up your Colleagues and Employees! GXPNews - W eekly It also contains administrative and tracking information about the applications and receipt and decision dates.įor additional information, please visit the FDA's Premarket Notification 510(k) page.GMP, QMS& 21 CFR Part 11 Webinar October 4th, 2022 The openFDA Device 510(k) Clearances API contains details about specific products and the original sponsors of premarket notification applications. The legally marketed device(s) to which equivalence is drawn is commonly known as the “predicate'.

A legally marketed device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found substantially equivalent through the 510(k) process. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.

Fda 510k database